Electrotherapeutic Device

ABSTRACT

This invention relates to an electrotherapeutic device useful for treating a variety of aspects associated with Carpal Tunnel Syndrome. The device is a TENS-like unit that is miniaturized, comfortable and unobtrusive, thereby allowing for unencumbered performance of daily activities. The device houses an electronic circuit comprising optimally placed electrodes and a microprocessor preprogrammed to deliver an optimal stimulus pulse protocol whereby the stimulus pulse parameters are varied so as to deliver a series of stimulus pulses for treating all aspects of CTS, including but not limited to pain blockage, nerve regeneration, reduction in inflammation and biochemical release.

RELATED APPLICATION

Benefit of priority under 35 U.S.C. 119(e) is claimed herein to U.S.Provisional Application No. 60/488,673, filed Jul. 18, 2003. Thedisclosure of the above referenced application is incorporated byreference in its entirety herein.

BACKGROUND OF THE INVENTION

Carpal Tunnel Syndrome (CTS) is the trapping of the median nerve in thewrist. Nerves are soft structures and they can become trapped at varioussites in the body. The median nerve is one of the many controlling themuscles of the arm and hand. It also relays sensation from the skin onthe back of the thumb, index and middle finger, and also from half ofthe ring finger. It runs from the elbow through the forearm to enter thewrist and hand on the same side as the palm.

Although the nerve can be damaged anywhere along its course, it is mostcommonly compressed at the point it enters the wrist. Here the nervelies in a tunnel (hence the use of the term Carpal Tunnel), the floor ofwhich is made up of bones and tendons in the wrist, and the ceiling is aband of tendon. If this “tunnel”—the carpal tunnel—becomes compressed,the median nerve is trapped and symptoms can occur.

Commonly, people with Carpal Tunnel Syndrome develop painful sensationsdescribed as “pins and needles” in the wrist and hand. The painfulsensations can be most severe in the thumb, index finger, and middlefingers; however, it may occur in other parts of the fingers, hand andwrist. The pain, which is usually worse at night, may also extend intothe arm. These symptoms may progress to numbness in the same areas andto weakness of the hand muscles. Weakness in several of the thumbmuscles makes it difficult to grasp objects between the thumb andforefingers. If the problem is not treated and the process leftunchecked, these muscles may shrink through disuse.

Many patients with CTS are unable to differentiate hot from cold bytouch, and experience an apparent loss of strength in their fingers.They appear clumsy in that they have trouble performing simple taskssuch as tying their shoes or picking up small objects.

Swelling of the tendons that line the carpal tunnel causes CTS. Althoughthere are many reasons for developing this swelling of the tendon, itoften results from repetitive and forceful movements of the wrist duringwork and leisure activities.

Research conducted by the National Institute for Occupational Safety andHealth (NIOSH) indicates that job tasks involving highly repetitivemanual acts, or necessitating wrist bending or other stressful wristpostures, are connected with incidents of CTS or related problems. Theuse of vibrating tools may also contribute to CTS.

One firm estimates that it costs a company $37,000 in lost work time,medical treatments and rehabilitation for each worker who develops CTS.Workman's Compensation figures estimate $6,000 to $10,000 per case,depending on whether one or both hands are involved; and estimate theaverage cost of a well-managed case would be $8,000. Because theincidence of CTS continues to increase (especially in work requiringrepetitive hand movements, particularly computer keyboard users), it isfinancially important to consider painless, non-invasive, non-surgicaltreatments, which are easily self administered by the patient while athome, at work or elsewhere, without sacrificing the quality oftreatment.

Treatment of CTS may involve surgery to release the compression on themedian nerve and/or use of anti-inflammatory drugs and hand splinting toreduce tendon swelling in the carpal tunnel. In addition to the abovementioned costs of surgery, such medical interventions have met withmixed success, especially when an affected person must return to thesame working conditions. Current non-surgical treatments include:over-the-counter analgesics; steroid cortisone injections; physicaltherapy; chiropractic therapy; osteopathy; acupuncture; massage;homeopathy; and support braces. However, many of these non-surgicalapproaches do nothing to address the source of the problem.

Transcutaneous Electrical Nerve Stimulation (TENS) is an accepted andwell-characterized mode of electrotherapy (Kahn, J., Principles andPractice of Electrotherapy, New York, Churchill Livingstone, 1987;Greene, R. W. et al., Transcutaneous Pain Control and/or MuscleStimulating Apparatus, U.S. Pat. No. 4,147,171). TENS is primarilyintended for pain relief via a nerve signal blocking mechanism, but ithas also been used to promote healing via reduction of carpal tunnelinflammation and the appropriate release of biochemicals (“TherapeuticGoals”).

Current TENS units are designed to deliver a single current, and requiremanual adjustment to vary any of the parameters; (i.e., pulse amplitude,pulse width, wave form, modulation, frequency, current and pulse times).Many patients benefit from a combined therapy in which a variety ofstimulus pulse parameters are used during different stages of therapy.The availability and use of combination electrotherapy methods is oftencritical to successfully treating CTS. Existing units require manualadjustments by the therapist or other user to achieve this combinationelectrotherapy approach to CTS management. Independent use of theseunits by a patient (per clinician instructions) as part of a completetreatment plan of managed self care, if at all feasible, is verydifficult because adjusting the pulse parameters for each treatmentsession creates inherent variability in the magnitude and duration ofsaid parameters. Such a problem is further exaggerated by thelay-patient who is charged with self-administering the combinationelectrotherapy via a personal unit. As such, the current units do notpromote the current trend in the health care field toward managed selfcare and effective treatment. Furthermore, involvement of the lay-useris dramatically increasing as more portable TENS units enter the market.Portable TENS devices available on the market include: TENZCARE, 3M Co.,St. Paul, Minn.; Premier TENS, American Imex, Irvine, Calif.; andProTENS, NTRON, Sugarland, Tex.

In addition to the problems associated with user involvement in settingthe TENS pulse parameters, there are several problems also associatedwith the electrodes that are used in TENS therapy. Electrodes generallyrequire adherence to the skin using tape or another adhesive-conductingmaterial. The tape or material becomes loose over time rendering theelectrodes and therapy ineffective. This is especially true in activepatients in which the activity (e.g., passive range of motion, lightexercise, normal daily activities) is prescribed as part of the overallrehabilitation therapy plan. Skin irritation may also occur with the useof these electrodes as a result of reactions to the adhesive materialsused.

Interferential therapy is a very effective TENS-based treatment that ishighly dependant on proper electrode placement. (T. W. Wing,Interferential Therapy: How it Works and What's New, The Digests ofChiropractic Economics, May/June 1992). Electrode placement is criticalto effective treatment for all TENS therapies, but due to the interplayof the electrodes in interferential therapy, placement becomes a morecritical component of delivering an effective therapy. Unfortunately,patients often lack the anatomic knowledge needed to effectively placethe electrodes themselves. As a result, interferential therapy is notfavorable as a self treatment therapy because patients will eithermisalign the electrodes thereby delivering a less than optimal therapyor the patient will have to make frequent clinic visits for electrodeplacement, which is impractical for a variety of reasons.

Accordingly, there exists a need for a miniaturized, portableelectrotherapy device capable of delivering multiple modes of stimuluspulse to a user's wrist for the purpose of treatment and therapy of CTS.The device must be unobtrusive; it must promote proper electrodeplacement; it must provide optimal therapy regimens through preciselyvaried stimulus pulse protocols; it must be comfortable enough to beworn on the body during everyday activities; and it must permit completefreedom of movement without fear that its parts will become loose ordetached. The present invention fulfills these needs and providesfurther related advantages.

BRIEF SUMMARY OF THE INVENTION

The present invention resides in an improved electrotherapy device whichis miniaturized and unobtrusive, thereby allowing for unencumberedperformance of daily activities. The device comprises a housing and anelectronics circuit. In a preferred embodiment, the housing of thecurrent device is a sleeve, preferably formed of a flexible elasticmaterial such as neoprene material; however, a variety of othermaterials can be used, including, but not limited to, elastic bandagematerial, which are often cotton or cotton plus another substance suchas polymide. The sleeve is worn around the affected wrist of a patientoffering, in addition to the electrotherapy as discussed below,compression to the affected arm.

The electronic circuit comprises embedded electrodes. The electrodes areoptimally placed to contact the desired anatomical area of a usersuffering from Carpal Tunnel Syndrome (CTS).

In one embodiment, electrodes are connected to the electronics circuitby a pair of lead wires originating from at least one socket on theelectronics circuit. In another embodiment, electrodes are in wirelesscommunication with the electronics circuit, thereby receivinginstructions wirelessly. In this embodiment, the electrode comprises awireless transceiver and a power source. The electrodes are positionedin the sleeve in a configuration for physically contacting specificmusculo-tendonous structures.

The electronic circuit of the invention also comprises a microprocessorpre-programmed to deliver an optimal stimulus pulse and a power source,preferably comprising at least one battery to provide the operationalpower supply for the invention.

In the embodiment wherein the electrodes communicate wirelessly with themicroprocessor, both the wireless electrodes and the microprocessorfurther comprise a wireless transceiver; and the electrodes stillfurther comprise a power source.

The electronics circuit comprises a microprocessor that ispre-programmed to deliver a stimulus pulse, and during the course of anelectrotherapy treatment, the pre-programmed microprocessor will varythe parameters of the stimulus pulse. The stimulus pulse is based ontranscutaneous electrical nerve stimulation (TENS) and includes thefollowing parameters: pulse amplitude, pulse width, wave form,modulation, frequency and pulse time. The microprocessor will changethese parameters at a precise time, to a precise degree and a precisesetting thereby specifically and optimally treating a variety of thecomplications associated with carpal tunnel syndrome (e.g., pain,inflammation, biochemical dysregulation, and neural impulse). Optimalchanges in stimulus pulse parameters for treating a particular disorderare well known in the art. Changing these parameters using amicroprocessor will avoid the inherent errors in timing, degree andsettings associated with manual adjustment. In the preferred embodiment,these changes in the parameters of the stimulus pulse are consistentwith defined stimulus pulse parameter changes as determined in the artof electrotherapy; however, any of a variety of changes is possible. Theelectronics circuit is embedded into the housing to prevent looseningduring movement. Each pre-programmed set of parameters is directed totreat a specific physical condition associated with CTS.

In the preferred embodiment, the electrode pairs are precisely placedaround the wrist so as to deliver a three dimensional quadripolarinterferential microcurrent to an affected area. In addition, a singleelectrode is placed at or near the palm of the hand in order tofacilitate the regeneration and healthy functioning of the medial nerve.

In an alternative embodiment, there is also included at least one remoteelectrode that is in communication with the control circuit (e.g., usinglead wires or using radio frequency). Said at least one remote electrodeis preferably placed at or near the trapezius muscles. The at least oneremote electrode preferably receives instructions from the controlcircuit using a wireless communication protocol. In this embodiment theat least one remote electrode comprises a microprocessor having awireless communication means; a power source; and an electrode. In analternative embodiment, the at least one remote electrode is connectedto the control circuit using a lead wire, and thus need only comprise anelectrode.

Other features and advantages of the invention will become apparent fromthe following more detailed description, taken in conjunction with theaccompanying drawings which illustrate by way of example, the principlesof the invention.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1 a and b are perspective views of the device in an open position.

FIG. 2 is an illustrative view of the device in use on the human wrist.

FIG. 3 is an illustrative view depicting electrode to electrodeelectrical contact during the delivery of three dimensional quadripolarinterferential current.

FIG. 4 is a perspective view of the device in an open position andhighlighting the at least one remote electrode and two alternativeembodiments wherein in one alternative embodiment, said at least oneremote electrode is hard wired to the remainder of the embeddedelectronics circuit, and wherein in a second embodiment, said at leastone electrode wirelessly communicates with the remainder of the embeddedelectronics circuit

FIG. 5 is a block schematic representing an electronic circuit usefulwith the device.

FIG. 6 is a schematic representing an electronic circuit useful with thedevice.

DETAILED DESCRIPTION OF THE INVENTION

As shown in the drawings for purpose of illustration, the currentinvention is concerned primarily with an improved electrotherapy device,generally designated in the accompanying drawings by the referencenumber 10. The device is specifically designed to be miniaturized,self-contained, and capable of affecting a plurality of differentstimulation pulse modes for treating carpal tunnel syndrome (CTS).

In accordance with the present invention, and as illustrated in FIGS. 1a and 1 b, and applicable with respect to the preferred embodiment, theimproved electrotherapy device 10 generally comprises a housing 12,which preferably further comprises a ventral-half 14 (i.e., fitting withthe palmar side of the wrist) and a dorsal-half 16 (i.e., fitting withthe back side of the wrist).

The housing 12 is in the form of a hinged sleeve adapted to fit around(conform anatomically to) the affected wrist and further comprises anextension to contact the palm. In the preferred embodiment, theventral-half 14 and dorsal-half 16 of housing 12 are connected using ahinged mechanism 18. The hinged mechanism allows housing 12 to open andclose around a user's wrist in a clam shell-like manner, whereinventral-half 14 and dorsal-half 16 are capable of rotation around thelongitudinal axis of said hinged mechanism 18. When in the closedposition, ventral-half 14 and dorsal-half 16 are capable of fasteningtogether using a fastener mechanism 20. Although a variety of fastenersare useful to achieve this aspect of the current invention, by way ofexample only, one such fastener is Shutter Pins 810 Series, (AlliancePlastics Finishing Products, Santa Fe Springs, Calif. 90670).

In an alternative embodiment, ventral-half 14 and dorsal-half 16comprise a fastener mechanism 20 on both connecting ends. In such anembodiment, said halves are capable of complete separation from eachother when open, and are directionally secured together using saidfastener mechanism 20. In still a further embodiment, ventral-half 14and dorsal half 16 comprise a retractable opening hinge on one or bothconnecting ends, thereby allowing for a partial separation of saidhalves so that a user can insert an arm into the device and then bringthe two halves together by retracting and fastening said retractableopening hinge.

In an additional embodiment, the two halves, ventral-half 14 and dorsalhalf 16, each comprise complementary male/female attachment mechanisms.This embodiment allows for total separation of the ventral-half 14 fromthe dorsal-half 16 via dissociation of the male and female members.Additionally, this embodiment allows for housing inserts to be insertedin between ventral-half 14 and dorsal-half 16 thereby creating a devicethat accommodates a variety of sized arms. Further embodiments arereadily apparent to those of skill in the art, and will be achieved allwithin the spirit of the current invention.

FIG. 2 illustrates one embodiment of the device in the closed positionas worn on a user's wrist. In this illustration, electrotherapy device10 is placed on a user's wrist and prong extension 22 extends into thepalm of the user's hand. Other embodiments may include illustrations ofadditional prong extensions 23 a, 23 b, 23 c and/or at least one remoteelectrode 101 (all discussed below). Although the device is shown on thewrist as applicable to treating CTS, those of ordinary skill in the artwill readily adapt the device to fit a variety of areas of both humanand animal bodies to treat a variety of disorders. By way of example,and not limitation, the current device can be fitted to a user's kneeand the electronic circuit pre-programmed to deliver a stimulus pulseprotocol useful for treating disorders of the knee.

In the preferred embodiment, ventral-half 14 of housing 12 furthercomprises prong extension 22, which, when housing 12 is in the closedposition on a user's wrist, is in contact with the palm of said user'shand. Prong extension 22 is useful for providing splint-like supportand/or may further comprise at least one electrode. Alternatively,Prongs may extend from ventral-half 14 on the forearm region and/oreither end of dorsal-half 16, forming prong extensions 23 a, 23 b and 23c, respectively. In a further alternative embodiment, housing 12 maycomprise no prong extensions.

Housing 12 is preferably constructed of a flexible and breathablematerial that offers the necessary support and comfort required to allowfor freedom of movement yet possessing sufficient rigidity to containthe electronic components (discussed below) and to provide an additionaltherapeutic effect by acting as a splint to support the wrist. Suchrigidity is useful in preventing the undesirable movements associatedwith repetitive stress injuries. In the preferred embodiment, housing 12is constructed of neoprene; however, those of ordinary skill in the artwill readily construct housing 12 from a material selected from thegroup consisting of, plastic, elastic, cotton, polymide, neopreme,rubber, neoprene and plaster and combinations thereof.

Housing 12 preferably comprises at least two pair of electrodes fordelivery of interferential therapy and more preferably comprises atleast four pair of electrodes for delivery of three dimensionalquadripolar interferential therapy (generally represented in theaccompanying drawings as a dark colored circle).

When housing 12 comprises two pair of electrodes, one pair of electrodes24 is embedded in the ventral-half 14, and the other pair of electrodes26 is embedded in the dorsal-half 16. (FIG. 1 a) Electrode pairs 24 and26 are positioned in housing 12 so as to facilitate the delivery ofinterferential, micro-current stimulation to the affected wrist area. Inone alternative embodiment wherein housing 12 comprises four pair ofelectrodes, electrode pair 24 and electrode pair 28 are positioned inthe ventral-half 14 and electrode pair 26 and electrode pair 30 arepositioned in the dorsal-half 16 so as to facilitate the delivery ofthree dimensional quadripolar interferential therapy to the affectedwrist area

An electrode 32 can also be placed in prong extension 22 in order todeliver a stimulus pulse to the palm of a user's hand. In oneembodiment, housing 12 comprises a total of nine electrodes: two pair ofelectrodes 24 and 28 are embedded in ventral-half 14; two-pair ofelectrodes 26 and 30 are embedded in dorsal half 16; and a singleelectrode 32 is embedded in prong extension 22. The same is true forprong extensions 23 a, 23 b and 23 c, which may comprise electrodes. Thetwo pair of electrodes embedded in the ventral-half 14 and the two pairof electrodes embedded in the dorsal-half 16 are positioned tofacilitate the delivery of three-dimensional quadripolar,interferential, micro-current stimulation to the affected wrist. Asshown in FIG. 3, quadripolar, interferential, micro-current stimulationutilizes an alternating electrical connection between electrode pairs24-26 and 24-28, as well as a synchronized alternating current betweenelectrode pairs 28-30 and 26-30. The principles of interferentialtherapies are well known in the art.

The single electrode 32 embedded in prong extension 22 is useful forstimulating the medial nerve in order to facilitate proper regenerationand function. Alternatively, any, all or a combination of prongextensions 22, 23 a, 23 b and/or 23 c may comprise an electrode (shownas gray circles in FIG. 1 b) for stimulating the medial nerve or otherarea of the user's forearm and hand.

Other electrode configurations are obvious to those of skill in the artin light of the current disclosure, including, but not limited to usingsix, eight or some other number of electrode pairs within housing 12 orusing electrode pairs that span the length of housing 12 to deliver abroad width of interferential, quad interferential or three dimensionalquad interferential micro-current to the affected wrist.

In the preferred embodiment, electrode pairs 24 and 28 are positionedwithin ventral half 14; electrode pairs, 26 and 30 are positioned withindorsal half 16; and single electrode 32 is optimally positioned withinprong extension 22 to contact the wrist and palm and to deliver adesired current to the carpal tunnel and the median nerve of the wrist.

Electrotherapy device 10 may further comprise at least one remoteelectrode 101. FIG. 4 illustrates an at least one remote electrode 101in one embodiment wherein a single at least one remote electrode 101 ishard wired to the electronics circuit (not shown) of ventral half 14,and illustrates an alternative embodiment wherein a single at least oneremote electrode 101 is in wireless communications with the electronicscircuit (not shown) of dorsal-half 16. Other embodiments are obvious tothose of ordinary skill in the art.

The at least one remote electrode 101 can be placed anywhere on the bodyand will send a stimulating pulse to that area of the body as instructedby the electrotherapy device 10. In the preferred embodiment, at leastone remote electrode 101 is placed on the trapezius muscle. Morepreferable, at least one remote electrode 101 is four electrodes placedon the trapezius muscle and an interferential therapy is delivered tosaid trapezius muscle. The trapezius muscle is preferable for placementof at least one remote electrode 101 because said muscle group has beenimplicated in CTS.

In one embodiment, as shown in FIG. 5, these electrodes (24, 26, 28, 30,32 and 101) connect with electronics circuit 34 through lead wires 36.Both electronics circuit 34 and lead wires 36 are completely embedded inhousing 12. In another more preferred embodiment the electrodes are incommunication with the electronics circuit 34 using a wirelesscommunication protocol. Wireless communication protocols are well knownin the art and include without limitation those defined by the IEEEstandards, for example IEEE 803.11 and IEEE 803.15, as well as othersdefined by protocols such as Bluetooth, Zigbee, and CDMA. In thepreferred embodiment, a wireless communication protocol that iscompatible with the Medical Implant Communication Service band (“MICsband”) is used because the low power requirements, falling in the rangebetween about 260 MHz and about 700 MHz, is ideal for the medicalindustry.

The electronics circuit 34 is small and has low profile housing so thatit is will be unobtrusive when embedded in housing 12. The electronicscircuit, in its preferred embodiment shown in FIG. 5, provides at leastthe following: the electrodes 24, 26, 28, 30, 32 and 101 (“Electrodes”in the drawing); an on/off power switch 38, a power source 40 amicroprocessor 42 and a function indicator 44.

On/off power switch 38 can be any switch known in the art that can beemployed with the current invention said switch being selected from thegroup consisting of mechanical single pole dual throw (SPDT) switches,bio-impedance switches, push button switches and point contact switches.

The on/off power switch 38 is preferably a SPDT placed on the outersurface of housing 12 within easy access for the user. In a furtherembodiment, switch 38 comprises a gap in the electrical circuit that isclosed by the surface of a user's skin when the housing 12 is clampedaround said user's body. Point contact switches comprise a similarconfiguration in that the electrical circuit is open when theelectrotherapy device 10 is not in use. The electric circuit is gappedacross the contact point of ventral half 14 and dorsal half 16 wherefastener mechanism 20 is located. When the two halves are placed incontact the electrical circuit is closed. These and other on/offswitches are well known in the art and will readily be employed with thecurrent invention.

Switch 38 controls power delivered to an electronic circuit by powersource 40 contained within the electronics circuit 34. Power source 40is preferably a primary cell battery, is more preferably a rechargeablebattery, is even more preferably an embedded power source, and is mostpreferably a telemetric power source. In an alternative embodiment,power source 40 can be a power cord hard wired into the electronicscircuit 34 and having an exposed plug for attachment into an AC walloutlet. This alternative embodiment is more useful with electrotherapydevices that will be used when a user's range of motion is limited, suchas in a hospital setting.

Microprocessor 42 is preferably pre-programmed for selecting androtating through stimulus pulse parameters. The stimulus pulse is basedon transcutaneous electrical nerve stimulation (TENS) and includes thefollowing parameters: pulse amplitude, pulse width, wave form,modulation, frequency and pulse time. The microprocessor will changethese parameters at a precise time, to a precise degree and a precisesetting thereby specifically and optimally treating a variety of thecomplications associated with carpal tunnel syndrome (e.g., pain,inflammation, biochemical dysregulation, and neural impulse). Optimalchanges in stimulus pulse parameters for treating a particular disorderare well known in the art. Changing these parameters using amicroprocessor will avoid the inherent errors in timing, degree andsettings associated with manual adjustment.

In the preferred embodiment, microprocessor 42 is pre-programmed todeliver a current having the optimal parameters (i.e., pulse amplitude,pulse width, wave form, modulation, frequency and pulse times) to treatCTS. Using the microprocessor 42, these changes take place at precisetime points during the treatment and said changes will meet the preciselevels for the changed parameters. As a result, pre-programmedmicroprocessor 42 delivers an optimal electrotherapy treatment, whichcan in turn reduce recovery time, avoid symptom occurrence and reducethe cost of CTS.

In an alternative embodiment, the microprocessor can be subsequentlyprogrammed, for example by up-loading software having instructionsrelating to the parameters of said stimulus pulses. Those of skill inthe art will readily program stimulus pulse parameters into amicroprocessor.

Function indicator 44, is preferably at least one light emitting diode(LED), and is useful for indicating to the user, whether theelectrotherapy device 10 is on or off, whether the power source is fullycharged, and whether the electrotherapy device is conducting a current.

FIG. 6 shows in block diagram form the schematic for the electronicscircuit 34 of the electrotherapy device 10. Power is delivered to theelectronic circuit by the power source 40, preferably battery orbatteries (e.g a single 9 V, or two 3 V lithium button cell batteries inseries to produce 6 V). The single-pole dual-throw (SPDT) switch 38provides an on/off function by interrupting the connection from thepositive battery terminal to the electronic circuit power bus (marked asVcc on components 48 and 50 in FIG. 6). A microprocessor 42 providescomplete control over the functioning of the electronic circuit 34 byexecuting a series of assembly language instructions (software) storedin programmable read-only memory within the microprocessor 42. Completedigital control over operational mode selection and intensity levelselection provides a greater measure of reliability, reproducibility,effectiveness and safety than what is available when the user is givencontrol over stimulus pulse parameter selection, programming and otheroperating characteristics. Digital control avoids the problems of tocurrent variability, treatment regimen inefficiency, and less thanoptimal overall treatment that is common, if not unavoidable, when theuser is give control of the operational mode selection and intensitylevel selection.

The function indicator 44, preferably an LED, provides the user withinformation regarding whether the electrotherapy device's 10 electronicscircuit 34 is on or off, is conducting current or is low on powerreserves. Low power (2 mA) LEDs are preferably used for functionindicator 44 to conserve battery power in power source 40. During normaloperation the function indicator correspondence remains on; however,when switch 38 is in the off position, or when unit 10, for some otherreason is not conducting current (e.g., dead battery), then functionindicator 44 is off. In an alternative embodiment, function indicator 44can comprise more than one LED, and various combinations of on/off forthe more than one LEDs indicates a variety of messages such as type oftherapy being delivered, duration or remaining time for the instanttherapy, remaining power in the power supply, or stimulus pulseparameter change.

The microprocessor 42 controls stimulus pulse frequency, duration andamplitude under the direction of the associated software. Themicroprocessor 42 provides a logical “high” voltage to the base ofeither transistor 48 or transistor 50, both of which may be high currentNPN or Darlington transistors, to turn the transistor on. A resistor(not shown) is placed in series at the base of each transistor to ensurethat the transistor enters saturation. Transistor 48 is used to generatea positive stimulation pulse (measured at subminiature output jack 52using subminiature jack 54 as reference). Similarly, transistor 50 isused to generate a negative stimulation pulse (measure the same as fortransistor 48). Only one of these transistors is in saturation (on) at atime, and the saturated transistor serves to connect either side of aprimary winding of a transformer 56 to positive voltage supply through alow resistance pathway. In an alternative embodiment, a current flowsensor 70 monitors the current from the pulse transformer 56 through theskin electrodes 52 and 54 and the user's skin. At least oneimplementation of this sensor is an optically coupled isolator poweredby the circuitry on the other side of the transformer (not shown in FIG.6). The sensor would provide feedback to the microprocessor block 42relating to the resistance and other bioelectrical properties of aparticular user's skin so that this block can adjust the power output ofthe device to obtain the desired result.

A centertap 58 of the transformer 56 is connected to the negativevoltage supply (ground) through a parallel array of transistors 60,which are used to control the current through the transformer primary 56to control the amplitude of the stimulus pulse. The transistor array 60is contained in a single integrated circuit, and the transistors may behigh current NPN (e.g., Harris semiconductor electronic part CA3081) orDarlington (e.g., Texas Instruments electronic part ULN2003). Acombination of the five transistors provides predefined varied pulseamplitude (intensity) levels. Each transistor in array 60 is underseparate control by the microprocessor 42, and each transistor in array60 is operated at saturation through a series resistor (not shown) atthe base of each transistor in array 60. The resistors R1 through R5 inseries respectively with the collector of each array 60 transistor areselected to provide discrete steps in the peak current through thetransformer 56, thus providing discrete control of the peak stimuluspulse amplitude (stimulus intensity). The values of the resistorsprovide linear or nonlinear discrete changes in stimulus intensity. Theresistor values are chosen to provide linear changes in stimulusamplitude with resistor some resistors and to provide maximum stimulusintensity with others. A positive stimulus pulse is generated by firstturning “on” transistor 48, then one of the transistors in array 60 isturned “on” to produce a particular stimulus amplitude. Both transistorsremain “on” for the duration of the stimulus, which is the pulse width.The end of the pulse is generated by turning the array 60 transistor“off” then turning “off” transistor 48. A negative stimulus pulse isgenerated in a similar fashion using transistor 50. Through transformeraction, a current pulse in the transformer primary winding produces acurrent pulse in the secondary winding, which is connected to theelectrodes via subminiature jacks 52 and 54. The current pulse in thesecondary winding is the stimulus pulse.

Solid state relays 62 and 64 selectively rectify the biphasic signalgenerated by transformer action using diodes 66 and 68 in order toproduce the currents used in the predefined pulse stimulus modes. Thesolid state relays 62 and 64 are selectively activated by themicroprocessor 42.

It is well known that excitable tissues will accommodate to stimulationunless the stimulation is modulated to prevent accommodation. Typicalmodulation schemes use amplitude modulation (the stimulation pulseamplitude is periodically changed while pulse duration and frequency areconstant), pulse width modulation (pulse width is periodically changedwhile pulse amplitude and frequency are constant), or frequencymodulation (pulse frequency is periodically changed while pulseamplitude and duration are constant). The modulation is typicallyrepresented by a triangle waveform, a sawtooth (repetitive ramps)waveform, or a sinusoidal waveform.

It is to be understood that the above description is intended to be isillustrative and not restrictive. Many embodiments will be apparent tothose of ordinary skill in the art upon reviewing the above description.The scope of the invention should therefore, be determined not withreference to the above description, but should instead be determinedwith reference to the appended claims, along with the full scope ofequivalents to which such claims are entitled. The disclosures of allarticles and references, including patent publications, are incorporatedherein by reference.

1. An electrotherapy device for treating carpal tunnel syndromecomprising: (a) a housing having a size and shape adapted to be worn onthe body; (b) a wrist support mechanism; (c) at least two pair ofelectrodes optimally placed to deliver an electrotherapy; (d) anelectronics circuit mounted within said housing and coupled to saidelectrodes; and (e) a microprocessor.
 2. The electrotherapy device ofclaim 1, wherein the housing is plastic and is adapted to be worn aroundthe wrist and palm of the body.
 3. The electrotherapy device of claim 2wherein the housing provides wrist support without impeding wristfunction.
 4. The electrotherapy device of claim 1, wherein the housingis a flexible sleeve and is adapted to be worn around the wrist and palmof the body.
 5. The electrotherapy device of claim 4, wherein the wristsupport mechanism further comprises a stiffening support member forproviding wrist support.
 6. The electrotherapy device of claim 1,wherein the first pair of electrodes is housed on the opposite side ofsaid electrotherapeutic device from said second pair of electrodes. 7.The electrotherapy device of claim 6, wherein said first and secondpairs of electrodes are optimally placed to allow for interferentialcurrents.
 8. The electrotherapy device of claim 1 wherein at least fourpair of electrodes are optimally placed in said device.
 9. Theelectrotherapy device of claim 8 wherein the four pair of electrodes areoptimally placed to deliver three dimensional quadripolar interferentialcurrent.
 10. The electrotherapy device of claim 1 wherein at least oneelectrode is optimally placed to deliver a longitudinal current to themedial nerve.
 11. The electrotherapy device of claim 1, wherein at leastone electrode is at least one remote electrode.
 12. The electrotherapydevice of claim 11, wherein the at least one remote electrode is placedon the user's shoulder muscles.
 13. The electrotherapy device of claim1, wherein the at least one electrode is physically coupled to theelectronics circuit using a wire.
 14. The electrotherapy device of claim1, wherein the at least one electrode is wirelessly coupled to theelectronics circuit using a wireless transceiver.
 15. The electrotherapydevice of claim 1, wherein the electronics circuit further comprises apower source, and wherein the power source is selected from the groupconsisting of primary cell batteries, rechargeable batteries, AC outletcords with plug, embedded power sources and telemetric power.
 16. Theelectrotherapy device of claim 1, wherein the microprocessor ispre-programmed to deliver a series of varied stimulus pulses through theelectronics circuit.
 17. The electrotherapy device of claim 16, whereinthe microprocessor is pre-programmed to vary the parameters of astimulus pulse, wherein the parameters of the stimulus pulse areselected from the group consisting of pulse amplitude, pulse width, waveform, modulation, frequency and pulse time.
 18. The electrotherapydevice of claim 16, wherein the pre-programmed variations in stimuluspulse parameters are optimal for relieving pain, for reducinginflammation, for facilitating nerve regrowth and for releasingbiochemicals.
 19. A method for the treatment of a disorder usingelectrotherapy consisting of: (a) applying an electrotherapy device toan affected area for delivery of electrotherapy treatment; (b) poweringthe electrotherapy device to deliver the treatment; and (c) receiving anelectrotherapy treatment as defined by a microprocessor wherein theparameters forming the stimulus pulses delivered are varied at precisetimes, precise degrees and precise settings.
 20. The method of claim 19,wherein the electrotherapy device is applied to the wrist of a user. 21.The method of claim 20, wherein at least one remote electrode is appliedto the shoulder muscles of a user.
 22. The method of claim 19, whereinthe electrotherapy treatment is an interferential therapy.
 23. Themethod of claim 19, wherein the electrotherapy treatment is threedimensional quadripolar interferential microcurrent therapy.
 24. Themethod of claim 19, wherein the microprocessor is pre-programmed to varythe parameters of the stimulus pulse in order to achieve an optimalelectrotherapy.
 25. The method of claim 24, wherein the parameters ofthe stimulus pulse are selected from the group consisting of pulseamplitude, pulse width, wave form, modulation, frequency and pulse time.26. The method of claim 19, wherein the electrotherapy is for thetreatment of carpal tunnel syndrome.
 27. The method of claim 26, whereinthe variations in stimulus pulse parameters are optimal for relievingpain, for reducing inflammation, for facilitating nerve regrowth and forreleasing biochemicals.